This trial is active, not recruiting.

Conditions sphincter ani incontinence, obstetric trauma
Treatment physical therapy (pt) and behavioral therapy (bt)
Sponsor TriHealth Inc.
Start date July 2012
End date October 2016
Trial size 65 participants
Trial identifier NCT01672697, 12005-TriHealth


Our primary objective is to determine if physical therapy (PT) and behavioral therapy (BT) in the post-partum period after a vaginal delivery complicated by genital trauma help to improve a woman's quality of life, specifically in regard to anal incontinence. To be able to study this, the investigators need to know how well the muscles of a woman's pelvic floor function after a vaginal delivery and this requires measuring their strength during a pelvic exam. At present, there are no studies that have looked at whether the intervention of PT/BT improves a woman's anal incontinence quality of life after sustaining genital trauma during vaginal deliveries

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Intervention Group: Randomized to Physical Therapy (PT) 2-week visit which includes: Demographic Data, Physical Exam, ehavioral Therapy (BT) handouts Functional questionnaires administered Physiologic measurements obtained Follow-up Evaluation-6-week visit PT session #1 Functional questionnaires administered Follow-up Evaluation-8-week visit PT session #2 Follow-up Evaluation-10-week visit PT session #3 Study Completion Visit-12-week visit Functional questionnaires administered PT session #4 Physiologic measurements Physical Exam Long-term Follow-up-24-weeks Functional questionnaires administered by mail
physical therapy (pt) and behavioral therapy (bt) Internal Pelvic Floor Physical Therapy
Physical Therapy (PT) Protocol states that each participant in the treatment arm only will undergo a total of four 45-minute sessions with a certified pelvic floor (PF) physical therapist over the course of the 12 weeks. Routine monitoring of patient progress will be performed. Each session includes using the body core muscles and internal pelvic floor muscles, focusing on PF protection techniques, PF exercises, Core exercises, progression to full ADLs(activities of daily living), and an exercise routine. Behavioral Therapy (BT) Instructions are given only to participants in the treatment arm after randomization at week-2 visit; handout provides specific instructions about appropriate diet, hygiene and level of activity during the 12 weeks of enrollment.
(No Intervention)
Control Group: Baseline Data obtained at 2-week visit Demographic Data General Physical Exam findings Functional questionnaires administered in person (FIQOL, FISI, SF-12, FSFI, UDI-6, IIQ-7) Physiologic measurements obtained (Vaginal EMG, Anal-rectal manometry) Follow-up Evaluation at 6-week visit Functional questionnaires administered in person at patient's previously scheduled postpartum office visit with primary Ob/Gyn or by mail Study Completion Visit at 12-week visit Functional questionnaires administered Physiologic measurements obtained Physical Exam findings Long-term Follow-up at 24-weeks - Functional questionnaires administered by mail

Primary Outcomes

Fecal Incontinence Quality of Life (FIQOL)
time frame: baseline (2-weeks post delivery) to completion (12-weeks post delivery)

Secondary Outcomes

Anal-rectal manometry (ARM)
time frame: baseline (2 weeks post delivery) to completion (12 weeks post delivery)

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Primiparous women aged 18 years of older - Vaginal delivery, vacuum-assisted-vaginal-delivery (VAVD), or forceps-assisted-vaginal-delivery (FAVD) of a neonate of gestational age: - 27 completed weeks - Singleton or vaginal delivery of multiple gestation - Able to read and speak the English language Exclusion Criteria: - Unable to comply with physical therapy or office visits - Unreliable transportation - Preexisting neurologic, musculoskeletal or neuromuscular disorder rendering them unable to perform physical therapy requirements - Cesarean delivery - History of prior surgery for anorectal incontinence (i.e. sphincteroplasty

Additional Information

Official title Effects of Physical Therapy on Pelvic Floor Symptoms and Quality of Life in Postpartum Women Following Severe Perineal Trauma: a Randomized Controlled Trial
Description This is a prospective trial involving 65 woman who sustained a severe laceration or episiotomy during their first vaginal delivery to determine if postpartum intervention with physical/behavioral therapy improves their quality of life in regard to anal incontinence. The primary outcome measure is functional and based on a change in score of the Fecal Incontinence Quality of Life (FIQOL) validated questionnaire from baseline (2-weeks after delivery date) to study completion (12-weeks after delivery date). The secondary outcome measure is physiologic and reflects a change in anal sphincter resting tone from baseline to study completion. After the screening questionnaires to determine eligibility in the study, each study subject will be consented for participation then undergo a baseline physical exam (including pelvic exam and rectal exam) at a range of 2- to 4- weeks after delivery date. In addition, after this initial exam, all women will be randomized immediately to receive (1) no further treatments, or (2) physical and behavioral therapy. The investigators will study these two groups of women for 24 total weeks after the date of delivery. The intervention group will include patients randomized to receiving PT/BT for 4 weekly sessions after their vaginal delivery and laceration (episiotomy) repair. The control group (no intervention) will include patients randomized to receiving the standard of care (no physical or behavioral therapy) after their vaginal delivery and laceration (episiotomy) repair. Each group will undergo the baseline testing: a pelvic exam (to measure the strength of your muscles) and anal-rectal manometry (i.e. rectal exam with insertion of a small sensor to measure the strength of your sphincter); and be asked to complete a series of brief questionnaires. These questionnaires will be administered again to both groups at 6-weeks, 12-weeks, and 24-weeks after their delivery date. Study completion physical exams including a repeat pelvic exam and repeat anal-rectal manometry will be conducted at 12-weeks after delivery date.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by TriHealth Inc..